This invention relates to the field of surgery and wound closure. More particularly, this invention relates to devices for applying medically-acceptable adhesives, such as 1,1-disubstituted ethylene monomers, to surgical sites.
Medical adhesives are used as alternates and/or adjuncts to sutures and staples as wound closure devices. As used herein, xe2x80x9cwoundxe2x80x9d encompasses all disruptions of animal tissue, regardless of manner inflicted, and includes, for example, wounds that are inflicted unintentionally, through surgery, and through natural causes (e.g., degeneration of tissue, infection, etc.) One group of medical adhesives is the monomeric forms of 1,1-disubstituted ethylene monomers, such as xcex1-cyanoacrylates. Members of this group are disclosed in, for example, U.S. Pat. Nos. 5,328,687 to Leung et al; U.S. Pat. No. 3,527,841 to Wicker et al.; U.S. Pat. No. 3,722,599 to Robertson et al.; U.S. Pat. No. 3,995,641 to Kronenthal et al.; and U.S. Pat. No. 3,940,362 to Overhults.
Applying medically acceptable adhesives to surgical sites for wound closure requires that the adhesive be dispensed in a precise and controlled manner to the site. Medical practitioners have encountered problems in applying this type of adhesive to internal organs and other deep tissues due to the current limited ability to evenly and controllably dispense an appropriate and accurate amount of the desired adhesive to the site to be closed. Although devices for delivering substances to wound sites are known in the art, none of the devices provide an adequate means for delivering a predetermined amount of adhesive to the site in a controlled and even manner.
For example, U.S. Pat. Nos. 5,222,939 and 5,372,585 to Tiefenbrun et al. disclose laparoscopic instruments that comprise a receptacle for storing a predetermined amount of a biologically active composition, and an ejector to mechanically inject the composition into a surgical site. These instruments rely on a piston to contact the biologically active composition and drive it through an elongated shaft of the laparoscopic instrument onto the site.
U.S. Pat. Nos. 5,312,333 and 5,415,631 to Churnitz et al. disclose endoscopic devices for delivering a metered quantity of material to an intended site of application within a body. The devices comprise a containment reservoir containing the material to be delivered either in the handle or at the endoscopic portion of the device. The devices utilize either a plunger which makes contact with the containment reservoir, or a propellant which forces the material from the distal end of the endoscopic devices.
U.S. Pat. No. 4,237,871 to Bonnet discloses a device for injecting pastes or fluid substances into human obturation organs by means of an injection tube which is axially displaceable through an endoscope shaft. The device disclosed by Bonnet utilizes a cylinder which is filled from the proximal end of the device with the fluid or paste to be delivered. The fluid or paste is then forced out of the cylinder by contact with a piston, which is actuated forward by the use of a mechanical screw thread. The piston causes delivery of the fluid or paste by exerting direct physical compressive force which forces the fluid or paste to extrude through the injection tube and thus to the site of interest.
U.S. Pat. No. 5,281,197 to Arias et al. discloses an endoscopic tool for repetitive dispensing of discrete units of a hemostatic agent The device disclosed by Arias et al. incorporates a hollow tube endoscopic device into which a plurality of individual, discrete units of a hemostatic agent is incorporated. The tool utilizes incremental movements of a plunger to contact the proximal most discrete unit and dispense the individual units of the agent.
U.S. Pat. No. 5,456,388 to Honstein et al. discloses a hand-held dispenser for delivering adhesives. The device disclosed by Honstein et al. comprises a cylindrical barrel containing a column of fluid or semi-fluid adhesive, and a cylindrical piston in direct contact with this column of fluid. Adhesive is dispensed from the device by rotation of a thumbwheel that is connected to the piston through a threaded rod. Turning the thumbwheel causes the piston to move against the fluid, resulting in displacement of the fluid and delivery of the fluid to a surface to be bonded.
Additionally, besides the difficulty in obtaining a precise amount of adhesive to internal organs and other deep tissues, it has been difficult to properly align and orient a wound or incision at such sites immediately prior to and during the adhesive application.
The present invention relates to a medical device for delivering liquid or semi-liquid compositions, such as adhesives, to an internal tissue or organ in an even and controlled manner. The device broadly comprises a pump, a tubular extension that is thin enough to pass through an endoscopic pathway or trocar, a proximal end of the tubular extension being sealingly connected to the pump, and an applicator tip that attaches to the distal end of the tubular extension. The tip includes the controlled amount of liquid and the pump pumps the liquid to the internal tissue in an even and controlled manner without contact of the liquid by the pump.
In a preferred embodiment, the pump comprises a micropipetter that includes a hand-held portion having a hand-actuatable plunger that does not come in direct, physical contact with the liquid to be dispensed. However, the invention can be practiced by lesser accuracy pumps such as syringes, diaphragms, gas pumps or pressurized gas pumps.
The present invention also relates to a method of use of the device to dispense a controlled amount of the composition to a site.
In another embodiment of the invention, the medical delivery device is further provided with a wound closure device.
The devices and methods of the present invention are particularly useful in the field of surgery, especially in the field of laparoscopic or endoscopic surgery where an even and controlled amount of a medically-acceptable adhesive is to be applied to a site on an internal tissue or organ The devices and methods provide improved control, ergonomics, and convenience compared to devices and methods currently known.
The use of medical delivery devices and wound closure devices of the present invention can provide even further control and effectiveness in the field of surgery, particularly laparoscopic or endoscopic surgery, as an internal wound or incision can be properly aligned and oriented at the site immediately prior to and during the adhesive application.